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Evaluation of Guideline Recommendations on Oral Medications for Type 2 Diabetes Mellitus: A Systematic Review

Wendy L. Bennett, MD, MPH; Olaide A. Odelola, MD, MPH; Lisa M. Wilson, ScM; Shari Bolen, MD, MPH; Saranya Selvaraj, BS; Karen A. Robinson, PhD; Eric B. Bass, MD, MPH; and Milo A. Puhan, MD, PhD
[+] Article and Author Information

From The Johns Hopkins University School of Medicine and The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Albert Einstein Medical Center, Philadelphia, Pennsylvania; and Case Western Reserve University at MetroHealth Medical Center, Cleveland, Ohio.


Note: This article is based on research conducted by the Johns Hopkins University Evidence-based Practice Center under contract to AHRQ.

Disclaimer: The authors of this article are responsible for its contents, including any clinical or treatment recommendations. No statement in this article should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

Acknowledgment: The authors thank Dr. Steven Fox for his assistance as the task order officer on the original contract and Dr. Deepan Dalal for his assistance reviewing guidelines.

Financial Support: By contract 290-02-0018 from AHRQ.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-1625.

Requests for Single Reprints: Wendy L. Bennett, MD, MPH, The Johns Hopkins University School of Medicine, 2024 East Monument Street, Room 2-611, Baltimore, MD 21205; e-mail, wbennet5@jhmi.edu.

Current Author Addresses: Dr. Bennett: The Johns Hopkins University School of Medicine, 2024 East Monument Street, Room 2-611, Baltimore, MD 21205.

Dr. Odelola: Department of Internal Medicine, Albert Einstein Medical Center, 5501 Old York Road, Philadelphia, PA 19141.

Ms. Wilson: The Johns Hopkins University School of Medicine, 1830 East Monument Street, Baltimore, MD 21287.

Dr. Bolen: MetroHealth/Case Western Reserve University, Center for Health Care Research and Policy, 2500 MetroHealth Drive, Rammelkamp Building, Room R234A, Cleveland, OH 44109.

Ms. Selvaraj: The Johns Hopkins University School of Medicine, 1830 East Monument Street, Room 8066, Baltimore, MD 21287.

Dr. Robinson: The Johns Hopkins University School of Medicine, 1830 East Monument Street, Room 8069, Baltimore, MD 21287.

Dr. Bass: The Johns Hopkins University School of Medicine, 1830 East Monument Street, Room 8068, Baltimore, MD 21287.

Dr. Puhan: The Johns Hopkins University Bloomberg School of Public Health, 615 North Wolfe Street, Mail Room E6153, Baltimore, MD 21205.

Author Contributions: Conception and design: W.L. Bennett, L.M. Wilson, S. Bolen, E.B. Bass, M.A. Puhan.

Analysis and interpretation of the data: W.L. Bennett, O.A. Odelola, L.M. Wilson, S. Bolen, K.A. Robinson, E.B. Bass, M.A. Puhan.

Drafting of the article: W.L. Bennett, O.A. Odelola, S. Selvaraj.

Critical revision for important intellectual content: W.L. Bennett, O.A. Odelola, L.M. Wilson, S. Bolen, K.A. Robinson, E.B. Bass, M.A. Puhan.

Final approval of the article: W.L. Bennett, O.A. Odelola, L.M. Wilson, S. Bolen, K.A. Robinson, E.B. Bass, M.A. Puhan.

Provision of study materials or patients: O.A. Odelola, L.M. Wilson, E.B. Bass.

Statistical expertise: W.L. Bennett, S. Bolen.

Obtaining of funding: E.B. Bass.

Administrative, technical, or logistic support: W.L. Bennett, L.M. Wilson, E.B. Bass.

Collection and assembly of data: W.L. Bennett, O.A. Odelola, L.M. Wilson, S. Bolen, S. Selvaraj, M.A. Puhan.


Ann Intern Med. 2012;156(1_Part_1):27-36. doi:10.7326/0003-4819-156-1-201201030-00005
Text Size: A A A

Background: Clinical practice guidelines have an important role in guiding choices among the numerous medications available to treat type 2 diabetes mellitus, but little is known about their quality.

Purpose: To assess whether guidelines on oral medications for type 2 diabetes are consistent with a systematic review of the current evidence and whether the consistency of the guidelines depends on the quality of guideline development.

Data Sources: MEDLINE, CINAHL, and guideline-specific databases were searched between July 2007 and August 2011, after the 2007 publication of a peer-reviewed systematic review on oral diabetes medications.

Study Selection: Two reviewers independently screened citations to identify English-language guidelines on oral medications to treat type 2 diabetes that were applied in the United States, United Kingdom, and Canada.

Data Extraction: Reviewers assessed whether the guidelines addressed and agreed with 7 evidence-based conclusions from the 2007 systematic review. Two reviewers independently rated guideline quality by using 2 domains from the Appraisal of Guidelines Research and Evaluation instrument.

Data Synthesis: Of the 1000 screened citations, 11 guidelines met the inclusion criteria. Seven guidelines agreed with the conclusion that metformin is favored as the first-line agent. Ten guidelines agreed that thiazolidinediones are associated with higher rates of edema and congestive heart failure compared with other oral medications to treat type 2 diabetes. One guideline addressed no evidence-based conclusions, and 5 guidelines agreed with all 7 conclusions. The summary scores of the rigor of development (median, 28.6% [range, 16.7% to 100.0%]) and editorial independence (median, 75.0% [range, 8.3% to 100.0%]) domains varied greatly across guidelines. Guidelines that received higher quality scores contained more recommendations that were consistent with the evidence-based conclusions.

Limitation: Only English-language guidelines targeting users in the United States, United Kingdom, and Canada that contained recommendations on oral medications were included.

Conclusion: Not all practice guidelines on oral treatment of type 2 diabetes were consistent with available evidence from a systematic review. Guidelines judged to be of higher quality contained more recommendations consistent with evidence-based conclusions. The quality of guideline development processes varied substantially.

Primary Funding Source: Agency for Healthcare Research and Quality.

Figures

Grahic Jump Location
Figure 1.
Summary of evidence search and selection.

* Total may exceed number in corresponding box because articles may be excluded for more than 1 reason.

† 11 guidelines published in 22 articles, including 10 updates.

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Figure 2.
Relationship between the editorial independence and rigor of development domain summary scores, by using the AGREE instrument.

AACE = American Association of Clinical Endocrinologists; ACE = American College of Endocrinology; ADA = American Diabetes Association; AGREE = Appraisal of Guidelines Research and Evaluation; CDA = Canadian Diabetes Association; EDC = Egyptian Diabetes Center; ICSI = Institute for Clinical Systems Improvement; IDF = International Diabetes Federation; Joslin = Joslin Clinical Oversight Committee; NICE = National Institute for Health and Clinical Excellence; Partners = Partners HealthCare; Yale = Yale Diabetes Center.

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Figure 3.
Relationship between rigor of development and editorial independence domain summary scores and consistency of guidelines with evidence-based conclusions.

The consistency of guidelines with evidence-based conclusions equals the number of conclusions agreed with out of 7. AACE = American Association of Clinical Endocrinologists; ACE = American College of Endocrinology; ADA = American Diabetes Association; CDA = Canadian Diabetes Association; EDC = Egyptian Diabetes Center; ICSI = Institute for Clinical Systems Improvement; IDF = International Diabetes Federation; Joslin = Joslin Clinical Oversight Committee; NICE = National Institute for Health and Clinical Excellence; Partners = Partners HealthCare; Yale = Yale Diabetes Center.

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Tables

References

Letters

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Comments

Submit a Comment
Italian Standards of Care and Guideline Recommendations on Oral Medications for Type 2 Diabetes Mellitus
Posted on January 15, 2012
Andrea, Giaccari, Endocrinology and Metabolic Diseases, Carlo B. Giorda, Gabriele Riccardi, Alberto De Micheli, Graziella Bruno, Luca Monge and Simona Frontoni
Policlinico Gemelli, Universita' Cattolica del Sacro Cuore, Rome, Italy
Conflict of Interest: None Declared

Dear Editor, we read the review by Bennett WL et al (1) with interest. Unfortunately, the Authors restricted their research to the U.S., U.K., and Canadian databases because they "deemed these countries' guideline developers most likely to access and use the systematic review". The Italian Standards for the Treatment of Diabetes Mellitus (2) represent a consensus document of the two Italian scientific diabetes societies (AMD and SID), providing specific recommendations for the diagnosis and treatment of diabetes and its complications. An original processing system was employed: the document prepared by the Editorial Team was published online for 20 days, and the suggestions and criticisms of all the Scientific Society members were evaluated and integrated with those provided by a panel of diabetologists and members of other healthcare professions committed to diabetes care, as well as lay members, including patients' representatives. These guidelines include recommendations on oral medications for Type 2 Diabetes Mellitus. In our opinion, the recommendation presented in the Italian Standards of Care fully fulfil the 7-item rigor of development domain of the Appraisal of Guidelines Research and Evaluation (AGREE) instrument (3) and we believe that, if taken into appropriate consideration, they would probably earn the best appraisal score in the Bennett WL et al re-evaluation. As all the examined guidelines, Italian Standards of Care propose metformin as first-line agent (upon and beyond lifestyle education) and acknowledge that most medications cause similar reductions in HbA1c, suggesting an accurate and personalized prescription behaviour based on well-known and demonstrated side effects, rather than intriguing, but still hypothetical, pathophysiologic choices. We would also like to specifically comment on the series of ADA/EASD documents; these algorithms are based on the personal opinion of experts, and generate consensus statements that are far from a guideline based on published evidence (4). This observation, for example, explains why the various versions of these consensuses substantially changed important medication choices over time, and is also the main reason that probably excluded their inclusion in the ADA Standards of Care. We are, therefore, glad that Bennett and co-workers indirectly appreciated our work in establishing Italian guidelines for the oral management of type 2 diabetes, and hope that a rigorous distinction between evidence-based guidelines and expert opinions will become more tangible.

References

1) Bennett WL, Odelola OA, Wilson LM, Bolen S, Selvaraj S, Robinson KA, Bass EB, Puhan MA. Evaluation of guideline recommendations on oral medications for type 2 diabetes mellitus: a systematic review. Ann Intern Med. 2012 Jan 3;156(1 Pt 1):27-36.

2) Bruno G, De Micheli A, Frontoni S, Monge L; Societa Italiana di Diabetologia - Associazione Medici Diabetologi (SID-AMD) Working Group on the Standards of Care for Diabetes. Highlights from "Italian Standards of care for Diabetes Mellitus 2009-2010". Nutr Metab Cardiovasc Dis. 2011 Apr;21(4):302-14.

3) Appraisal of Guidelines Research and Evaluation Collaboration. AGREE Instrument. 2010. Accessed at www.agreetrust.org/ on 13 January 2012.

4) Schernthaner G, Barnett AH, Betteridge DJ, Carmena R, Ceriello A, Charbonnel B, Hanefeld M, Lehmann R, Malecki MT, Nesto R, Pirags V, Scheen A, Seufert J, Sjoh?lm A, Tsatsoulis A, DeFronzo RA. Is the ADA/EASD algorithm for the management of type 2 diabetes (January 2009) based on evidence or opinion? A critical analysis. Diabetologia. 2010 Jul;53(7):1258-69.

Conflict of Interest:

None declared

Significant omission impacting on completeness
Posted on February 1, 2012
John R, Petrie, Professor of Diabetic Medicine, Keith Brown
University of Glasgow
Conflict of Interest: None Declared

Dear sirs -

We were interested to read your systematic review on the evaluation of guideline recommendations on oral medications for type 2 diabetes mellitus.[1] We were surprised, however, by the omission of the 2010 update of the Scottish Intercollegiate Guidelines Network guideline on the management of diabetes (SIGN 116, available for free download at www.sign.ac.uk).[2] This guideline covers all aspects of diabetes, with a specific chapter addressing medication for Type 2 diabetes - therefore meeting your main inclusion criteria.

In relation to your other inclusion criteria, SIGN guidelines provide evidence-based guidance for the National Health Service in Scotland, a constituent part of the United Kingdom. Health care is one of the areas of public policy devolved from the UK government to the Scottish Government, so any consideration of health provision in the UK as a whole has to take account of policies and advice on both sides of the border.

We suggest that omission from this systematic review of SIGN 116 is significant, impacting on its completeness.

Yours sincerely,

Dr. Keith Brown, Chair of Scottish Intercollegiate Guidelines Network (SIGN) keithbrown@nhs.net

Prof. John Petrie MD, Professor of Diabetic Medicine, University of Glasgow, (Chair of Type 2 Diabetes Subgroup, SIGN 116)

John.Petrie@glasgow.ac.uk

Scottish Intercollegiate Guidelines Network Delta House | 50 West Nile Street | Glasgow G1 2NP

www.sign.ac.uk

The Scottish Intercollegiate Guidelines Network is part of Healthcare Improvement Scotland.

References.

1. Bennett WM, Wilson LM, Bolen S, Selvaraj S, Robinson KA, Bass EB, et al. Evaluation of Guideline Recommendations on Oral Medications for Type 2 Diabetes Mellitus. A Systematic Review. Ann Int Med 2012: 156(1 Pt 1); 27-37.

2. Scottish Intercollegiate Guidelines Network. Management of diabetes: a national clinical guideline. Edinburgh: SIGN; 2010. (SIGN Guideline 116). Available from http://www.sign.ac.uk

Conflict of Interest:

Dr Petrie has provided consultancy and/or served on trial committees for pharmaceutical companies manufacturing products for the treatment of diabetes including BMS Pharma, Daaichi Sankyo, GSK, Novo Nordisk, Pfizer, Roche, and Takeda.

Author's Response
Posted on March 1, 2012
Wendy L., Bennett, MD, MPH, Olaide A. Odelola, MD, MPH, Lisa M. Wilson, ScM
The Johns Hopkins University School of Medicine
Conflict of Interest: None Declared

RESPONSE

We appreciated the letters by Drs. Brown and Petrie, and Drs. Giaccari and Giorda.   In addition to these letters we received e-mails from guideline developers concerned about several missed guidelines related to oral medication treatment for type 2 diabetes.   Our team conducted a careful review of our search strategy and unfortunately identified guidelines that should have been captured in our updated searches of the National Guidelines Clearinghouse (NGC).   We discussed our concerns with NGC staff members and identified several problems with our broad search (‘type 2 diabete *’).   Most importantly, the NGC website, including the search function, was modified during the summer of 2010, altering its translation of our search strategy and thus yielding fewer guidelines.   Although publicized on the NGC website, the announcement had already been archived at the time of our search.   The NGC staff proposed solutions to improve the practice of conducting systematic, repeated searches of guideline databases.   They advised us to use multiple search approaches, including a search for both the condition and medications of interest, and hand-searching the guidelines using the MeSH headings in the topic list.

To identify guidelines we had missed in our original search, we used the methods proposed by the NGC staff members in the 3 guideline-specific databases, the NGC database (U.S.), the National Library of Guidelines (U. K.) and the Canadian Medical Association Infobase: Clinical Practice Guidelines (Canada) from July 2007 to August 2011 (our original search dates).   We identified 9 additional guidelines that met our original inclusion criteria (1) , but had been missed in the original search (Table 1).   As noted in the letter by Drs. Brown and Petrie, we had missed The Scottish Intercollegiate Guidelines Network (SIGN) guideline (2) on the management of diabetes.   In fact, the SIGN guideline’s rigor of development and editorial independence domain quality summary scores were 97.6 and 100 percent (with possible range from 0=lowest to 100=highest percent), respectively, comparable to the highest quality guidelines we previously reported (1) .   In addition, The U.S. Department of Veterans Affairs-Department of Defense guideline was notable with consistently high quality scores and agreement with 6 of the 7 evidence-based conclusions from the 2007 Evidence report (Table 1) (3) .

Unfortunately, as Drs. Giaccari and Giorda noted in their letter, our database searches were restricted to U.S., U.K. and Canadian databases, and The Italian Standards for the Treatment of Diabetes Mellitus (4) was not included.   Therefore we are unable to comment on its agreement with the 7 conclusions from the 2007 Evidence Review (5) or quality.

 

Wendy L. Bennett, MD, MPH

Olaide A. Odelola, MD, MPH

Lisa M. Wilson, ScM

 

The Johns Hopkins University School of Medicine

Reference List

 

  (1)   Bennett WL, Odelola OA,   Wilson LM, Bolen S, Selvaraj S, Robinson KA et al. Evaluation of guideline recommendations on oral medications for type 2 diabetes mellitus: a systematic review. Ann Intern Med. 2012 ;156:27 -36.

  (2)   Scottish Intercollegiate Guidelines Network (SIGN). Management of diabetes. A national clinical guideline.   2010. Edinburgh Scotland, Scottish Intercollegiate Guidelines Network (SIGN).

  (3)   Department of Veteran Affairs, Department of Defense. VA/ DoD clinical practice guideline for the management of diabetes mellitus.    2010. Washington DC, Department of Veterans Affairs, Department of Defense.

  (4)   Bruno G, De Micheli A, Frontoni S, Monge L. Highlights from "Italian Standards of care for Diabetes Mellitus 2009-2010". Nutr Metab Cardiovasc Dis. 2011 ;21:302 -14.

  (5)   Bolen S, Feldman L, Vassy J, Wilson L, Yeh HC, Marinopoulos S et al. Systematic review: comparative effectiveness and safety of oral medications for type 2 diabetes mellitus. Ann Intern Med. 2007 ;147:386 -99.

  (6)   Handelsman Y, Mechanick JI, Blonde L, Grunberger G, Bloomgarden ZT, Bray GA et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract . 2011 ;17 Suppl 2:1-53.

  (7)   Aspray , T. J., Yarnall , A. J., Croxson , S. C., Chillala , J., and Sinclair, A. J. British Geriatrics Society Best Practice Guide: Diabetes.   2009.

  (8)   Canadian Agency for Drugs and Technologies in Health (CADTH). Optimal therapy recommendations for the prescribing and use of second-line therapy for patients with diabetes inadequately controlled on metformin .   2010. Ottawa Ontario, Canadian Agency for Drugs and Technologies in Health (CADTH).

  (9)   CADTH Therapeutic Review Panel. Third-line therapy for patients with type 2 diabetes inadequately controlled with metformin and a sulfonylurea.   2010. Ottawa Ontario, Canadian Agency for Drugs and Technologies in Health (CADTH).

(10)   Diabetes Coalition of California, California Diabetes Program. Basic guidelines for diabetes care.   2009. Sacramento CA, Diabetes Coalition of California, California Diabetes Program.

(11)   University of Michigan Health System. Management of type 2 diabetes mellitus.   2008. Ann Arbor MI, University of Michigan Health System.

(12)   Wisconsin Diabetes Prevention and Control Program. Wisconsin diabetes mellitus essential care guidelines.   2011. Madison WI, Wisconsin Diabetes Prevention and Control Program.

(13)   Appraisal of Guidelines for Research and Evaluation Collaboration. AGREE Instrument.   2010. Access at: www.agreecollaboration.org/instrument on 15 September 2011.

 

Table 1. Clinical practice guidelines with recommendations related to oral medication treatment for type 2 diabetes that were missed in the original search

Sponsoring organization

 

Year

Guideline scope

Basis for the Recommendations

# agreed with evidence based conclusions 1

Rigor of Development quality summary score, % 2

Editorial independence quality summary score, % 2

American Association of Clinical Endocrinologists

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